Trial · NCT01232920
First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial
NCT01232920, Phase 3, Completed, University of California, San Francisco; results first posted 2016-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial. Trials, record NCT01232920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01232920
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First-line Antimetabolites as Steroid-sparing Treatment Uveitis Pilot Trial
- NCT number
- NCT01232920
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 80 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Uveitis
- Interventions
- Methotrexate, Mycophenolate mofetil
- First posted
- 2010-11-02
- Last updated
- 2016-07-15
- Results first posted
- 2016-01-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Treatment Success | 6 months | TREATMENT SUCCESS is defined as controlled ocular inflammation in both eyes with less than or equal to 10 mg/day of prednisone and/or 2 topical steroid drops/day sustained for 2 visits separated by at least 28 days (control of inflammation and prednisone dose must be achieved by 5-month visit and sustained until 6-month visit). Discontinuation of study medication at any time due to efficacy, tolerability, or safety may result in a declaration of TREATMENT FAILURE. Note that all patients will be classified as either a treatment success or failure. |
| Secondary | Time to Control of Inflammation | 6 months | |
| Secondary | Change in Best Spectacle-corrected Visual Acuity (BSCVA) | 6 months | Change in best spectacle-corrected visual acuity (BSCVA) from baseline. Analysis on eye level |
| Secondary | Number of Eyes With Resolution of Macular Edema | 6 months |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Treatment Success | 6 months | participants | NUMBER | |
| SECONDARY | Time to Control of Inflammation | 6 months | days | MEDIAN | |
| SECONDARY | Change in Best Spectacle-corrected Visual Acuity (BSCVA) | 6 months | LogMAR | MEAN | |
| SECONDARY | Number of Eyes With Resolution of Macular Edema | 6 months | Eyes | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Treatment Success | Methotrexate | 24 | participants | ||
| Number of Participants Achieving Treatment Success | Mycophenolate Mofetil | 15 | participants | ||
| Time to Control of Inflammation | Methotrexate | 139 | Inter-Quartile Range 62.5 to 142 | days | |
| Time to Control of Inflammation | Mycophenolate Mofetil | 124 | Inter-Quartile Range 60 to 156 | days | |
| Change in Best Spectacle-corrected Visual Acuity (BSCVA) | Methotrexate | -0.26 | Standard Deviation 0.33 | LogMAR | |
| Change in Best Spectacle-corrected Visual Acuity (BSCVA) | Mycophenolate Mofetil | -0.19 | Standard Deviation 0.36 | LogMAR | |
| Number of Eyes With Resolution of Macular Edema | Methotrexate | Eyes with Macular Edema at Baseline | 22 | Eyes | |
| Number of Eyes With Resolution of Macular Edema | Mycophenolate Mofetil | Eyes with Macular Edema at Baseline | 13 | Eyes | |
| Number of Eyes With Resolution of Macular Edema | Methotrexate | Eyes with Resolved Macular Edema | 17 | Eyes | |
| Number of Eyes With Resolution of Macular Edema | Mycophenolate Mofetil | Eyes with Resolved Macular Edema | 7 | Eyes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methotrexate | 41 | |
| Overall Study | STARTED | Mycophenolate Mofetil | 39 | |
| Overall Study | COMPLETED | Methotrexate | 35 | |
| Overall Study | COMPLETED | Mycophenolate Mofetil | 32 | |
| Overall Study | NOT COMPLETED | Methotrexate | 6 | |
| Overall Study | NOT COMPLETED | Mycophenolate Mofetil | 7 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Methotrexate | 6 | 41 | |
| other | Nausea | Gastrointestinal disorders | Mycophenolate Mofetil | 2 | 39 | |
| other | Diarrhea | Gastrointestinal disorders | Methotrexate | 4 | 41 | |
| other | Diarrhea | Gastrointestinal disorders | Mycophenolate Mofetil | 4 | 39 | |
| other | Vomiting | Gastrointestinal disorders | Methotrexate | 3 | 41 | |
| other | Vomiting | Gastrointestinal disorders | Mycophenolate Mofetil | 2 | 39 | |
| other | Systemic infection | Infections and infestations | Methotrexate | 3 | 41 | |
| other | Systemic infection | Infections and infestations | Mycophenolate Mofetil | 4 | 39 | |
| other | Cataract | Eye disorders | Methotrexate | 5 | 41 | |
| other | Cataract | Eye disorders | Mycophenolate Mofetil | 3 | 39 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methotrexate | ||
| Total, all-cause mortality | Mycophenolate Mofetil | ||
| Total, other adverse events | Methotrexate | 33 | 41 |
| Total, other adverse events | Mycophenolate Mofetil | 32 | 39 |
| Total, serious adverse events | Methotrexate | 0 | 41 |
| Total, serious adverse events | Mycophenolate Mofetil | 1 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28414043 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methotrexate vs Mycophenolate Mofetil: Number of Participants Achieving Treatment Success | Trial comparisons |
| Methotrexate vs Mycophenolate Mofetil: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01232920
GET https://conductscience.org/api/trials/v1/NCT01232920/registered